Cinacalcet Hydrochloride

ANDA 210207, held by Piramal. Cinacalcet Hydrochloride.

As of Nov 15, 2026, ANDA 210207 (Cinacalcet Hydrochloride), held by Piramal, was first approved by FDA on Aug 1, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 1, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 1, 2018	Original application	Approved	None posted

Products

3 strengths and forms


Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral	Cinacalcet Hydrochloride	Rx
Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral	Cinacalcet Hydrochloride	Rx
Cinacalcet HydrochlorideEQ 90MG BASE · tablet;oral	Cinacalcet Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 22, 2024	Supplement 4Labeling · Standard review	Approved	None posted
May 18, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Aug 1, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210207
Drugs@FDA: Overview at FDA
Company: Piramal

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters